HoMedics TE-350-EU Service Manual

HTD8816C TE-350-EU

2 YEAR GUARANTEE

FOREWORD

The Non-Contact Infrared Body Thermometer operating Instructions intend to provide the necessary information for proper operation of the thermometer model. Only body mode was reviewed and certiﬁed by notiﬁed body. General knowledge of Infrared thermometer and an understanding of the features and functions of the thermometer model are prerequisites for proper use. The Non-Contact Infrared Body Thermometer is a medical device, and can be used repeatedly for the product’s recommended lifetime of 5 years. Please read the manual ﬁrst before using it, if not fully understand the usages, please stop using the thermometer.

Do not operate the thermometer without completely reading and understanding these instructions.

Notice

Purchase or possession of this device does not carry any express or implied license to use with replacement parts which would, alone or in combination with this device, fall within the scope of one of the relating patents.

For further information contact:

HoMedics Group Ltd, Somerhill Business Park, Five Oak Green Road, Tonbridge, Kent TN11 0GP. Customer Service: service@homedics.co.uk

Company Name: Wellkang Ltd Company Address: 16 Castle St, Dover, CT16 1PW, UK Tel: +44 (20)30869438, 32876300 Fax: +44(20)76811874 Web: www.CEmark.com, www.CE-marking.com, www.CE-marking.eu, Email: AuthRep@CE-marking.eu

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SAFETY INFORMATION

This device may only be used for the purposes described in these instructions. The manufacturer cannot be held liable for damage caused by incorrect application. The Non-Contact Infrared Body Thermometer is designed to minimize the possibility of hazards from errors in the software program by following sound and light engineering design processes, Risk Analysis and Software Validation.

WARNING

Warnings are identiﬁed by the WARNING symbol shown above.

• The Non-Contact Infrared Body Thermometer is to be operated by consumers in the home setting and primary care setting as screening tool. This manual, accessories, Directions for Use, all precautionary information, and speciﬁcations should be read before use.

• This product is designed to measure human body temperature on the forehead. Do not use it for any other purpose.

• This product is intended for use in the home setting and primary care setting as screening tool.

• Do not use the thermometer if it malfunctions or has been damaged in any matter.

• When the ambient temperature of the thermometer changes too much, such as moving the Thermometer from one place of lower temperature to another place of higher temperature, allow the thermometer to remain in a room for 30 minutes where the temperature is between 15°C to 40°C (59°F- 104°F).

• Remove primary batteries if equipment is not likely to be used for long time.

• This product is not waterproof, do not immerse in water or other liquid; If cleaning and disinfecting, please follow the “Care and Storage” section requirements.

• Do not touch the sensor of infrared detection with your ﬁngers.

• Avoid using the thermometer to take a body temperature reading while using a cold compress or other measure to reduce fever.

• If measuring human forehead temperature, please select “body” mode; for measuring other objects, liquids, food and other temperature please select “surface” mode.

• This product must be operated in a stable environment. If the ambient environment is unstable, please check whether there is fog on the sensor and remove this before using in accordance with the “Care and Storage” section.

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• Do not near strong electrostatic ﬁeld or strong magnetic ﬁelds, thus avoiding the impact on the accuracy of the measurement data.

• Do not mix the old and new batteries to avoid damage to the product.

• It may aect the accuracy of measurements when the forehead is covered by hair, perspiration, cap or scarf.

• The measuring result of this product is only for your reference. If you have any doubt, please measure the temperature in other methods.

The device should be kept out of the reach of children/pets. When not in use, store

the device in a dry room and protect it against extreme moisture, heat, lint, dust and direct sunlight. Never place any heavy objects on the thermometer body.

Do not throw batteries into ﬁre. Only use recommended batteries. Do not use rechargeable batteries. This thermometer does not replace a hospital diagnosis. Do not drop, disassemble or modify the device. Do not use this device if you think it is damaged or notice anything unusual. This device comprises sensitive components and must be treated with caution.

Observe the storage and operating conditions described in the ‘Technical

Speciﬁcations’ section.

Not servicing/maintenance while the thermometer is in use. When using, shall not touch battery and the patient simultaneously. Do not use the device if it is damaged/ degraded/loosened in any way. The continuous

use of a damaged unit may cause injury, improper results, or serious danger.

Based on the current science and technology, other potential allergic reactions are

unknown.

This equipment needs to be installed and put into service in accordance with the

information provided in the ACCOMPANYING DOCUMENTS.

OVERVIEW

Intended Use

The HoMedics Non-Contact Infrared Body Thermometers are designed to be used for intermittent measurement and monitoring of human body temperature by consumers in the home setting and primary care setting as screening tool.

Description of Non-Contact Infrared Body Thermometer

• Device principle and introduction

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• The HoMedics Non-Contact Infrared Body Thermometer is a hand-held, reusable,

battery operated device, which can measure human body temperature on forehead, the skin temperature on one’s forehead.

• The operation principle is based on Infrared Sensor technology. The IR sensor can output dierent signal when measuring dierent object temperature or in dierent ambient temperature, and the ASIC can turn the signal from IR Sensor to a digital value and display it on the LCD.

• Description on Controls, Indicators, and Symbols

Figure 1: Non-Contact Infrared Thermometer

1. IR sensor

2. Liquid crystal display (LCD)

3. MODE button

4. MEMO button

5. ON/scan button

6. Battery cover

7. Surface mode

8. Body mode

9. Data indicator

10. Indicator of measurement results

11. Low Battery indicator

12. Voice on/o indicator

13. Memory number

14. Fahrenheit

15. Celcius

16. Memory indicator

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THERMOMETER APPLICATIONS

1cm-5cm

Thermometer Model Number

HTD8816C

TE-350-EU

EQUIPMENT SYMBOLS

Thermometer Style

Non-Contact Infrared Body Thermometers

Adult Pediatric

Ear Forehead Ear Forehead

ü ü

Warning Restriction of Hazardous Substances

Non-sterile packaging Batch code

Refer to operating instructions Compliance with WEEE Standard

Operating Temperature

DO NOT THROW AWAY Intended for multiple use

Operating Humidity Operating atmospheric pressure

This device compiles with Part 15 of FCC (Federal Communications Commission) Rules.

Manufacturer

Recyclable Serial number

IP22: The ﬁrst number 2: Protected against solid foreign objects of Ф 12.5 mm and greater. The second number: Protected against vertically falling water drops when enclosure

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Indicates this device is in compliance with MDD 93/42/EEC. 0598 is the Notiﬁed Body Number

Authorized Representative in the European community

TECHNICAL SPECIFICATIONS

Measurement unit °C/°F

Operating mode Adjusted mode (Body mode)

Reference Body Site Axillary

Rated output range Body mode:

Output range Body mode:

Laboratory Accuracy Body mode:

Display Resolution 0.1°C/0.1°F

Three-colour Backlight (Colour Alarm)

Auto Power O Time ≤18s

Measuring Time ≤ 2s

Measuring Distance 1 - 5cm (0.4 - 2 in)

Memories 50

Direct mode (surface mode)

34.0 - 43.0°C / 93.2 - 109.4°F Surface mode: 0 - 100.0°C / 32 - 212°F

34.0 - 34.9°C: ± 0.3°C / 93.2 - 94.8°F: ± 0.5°F

35.0 - 42.0°C: ± 0.2°C / 95.0 - 107.6°F: ± 0.4°F

42.1 - 43.0°C: ± 0.3°C / 107.8 - 109.4°F: ± 0.5°F

Surface mode: ± 2°C / ± 3.6°F

35.5 - 37.3°C / 95.9 - 99.1°F: Green (Normal Temperature)

37.4 - 38.0°C (Alarm point) / 99.3 - 100.4°F: Yellow (Slight Fever)

38.1 - 43.0°C / 100.6 - 109.4°F: Red (High Fever) Note: 1. Surface mode is always with Green backlight

2. In body mode 34.0-35.4°C is with green backlight

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Power Supply Requirements

Batteries 2 x 1.5V (AAA) Alkaline battery (IEC Type LR03)

Adaptable Range 2.6V - 3.6V

Environmental

Operating Condition Operating Temperature:

Transport and Storage Condition

Dimension and Weighting

Weight (without batteries) 80g

Size L:122mm X W:96mm X H:42mm

Compliance

Item Compliant with

Equipment classiﬁcation Safety Standards:

Type of protection Internally powered equipment (on battery power)

Degree of protection Non-Applied part

Front panel and case labelling EN ISO15223-1:2016

Temperature EN ISO80601-2-56:2017

Home healthcare environment EN 60601-1-11:2015

15 - 40°C (59 - 104°F)

Storage Temperature:

-20 - 55°C (-4 - 131°F)

Relative Humidity: ≤ 85%

Relative Humidity: ≤ 93%

EN 60601-1: 2006+A1:2013, EN 60601-1-2: 2015

Atmospheric pressure: 70-106Kpa

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Calculated values of the indicators according to ISO 80601-2-56

Indicators Calculated value

Clinical bias, rcb

Standard deviation, σj 0.14

Limits of agreement, LA 0.26

Clinical repeatability, σr 0.07

Note: the above value is calculated from clinical data of HTD8818A.

-0.027

Safety classiﬁcation of ME EQUIPMENT

Protection against electric shock Internally powered ME equipment

Applied part Non-Applied part

Protection against harmful ingress of water or particulate matter

Mode of operation Continuous operation

Note: Not intended to be sterilized. Not for use in an OXYGEN RICH ENVIRONMENT.

IP22

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OPERATION

1cm-5cm

Battery installation

Caution: The Non-Contact Infrared Body Thermometer does not operate with dead batteries or external power sources. Install new batteries.

1. Slide the battery door downward, toward the bottom of the Non-Contact Infrared Body Thermometer, and remove the battery access door;

2. Insert two pieces AAA size batteries according to the “+” and “-”;

3. Close the battery cover.

How to operate

Before applying the Thermometer, be sure to read and understand all warnings listed of the instructions before use.

• The thermometer is aligned with the middle of the forehead to measure body temperature between the eyebrows above and keep the vertical distance, press the On/scan button, temperature will display immediately, see ﬁgure 2.

Figure 2: Measuring position and distance

• The ambient temperature around the test person should be stable, should keep away from the larger ﬂow fan, air-conditioning vents and so on.

• When people moving from one place of lower temperature to another place of higher temperature, should at least remain in the test environment more than 5 minutes, to be consistent with the ambient temperature after the re-measurement.

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• Wait at least 1 second for the next measurement. If the continuous measurement

1cm-5cm

of ﬁve times, it is recommended to wait at least 30 seconds and then continue measurement.

• You cannot use the thermometer in place where the sun is strong.

• If for some reason the forehead temperature measurement is low, try measurement behind the ears. See ﬁgure 3.

1cm-5cm

Figure 3: Align behind the ears to measurement

GENERAL SET UP AND USE

Start measuring

1. Turn on the thermometer by pressing the On/scan button. The thermometer will perform self-test with all segments displayed for 2 seconds.

2. Align the thermometer with the forehead, keeping the recommended distance, and then press the ON/scan button to start the measurement. Data reading will be displayed.

Note:

1. After measurement you will hear a “beep beep beep” three times which means that the measurement is complete. The temperature is displayed on the LCD. The LCD backlight colour will change red, green or yellow according to the measurement. Green means Normal Temperature (35.5-37.3°C / 95.9-99.1°F) ready for next measurement. Yellow means Slight Fever Warning (37.4-38.0°C /

99.3-100.4°F) Please pay attention to body temperature. Red means High Fever (38.1-43.0°C / 100.6-109.4°F) Please take action to cool down or go to the doctor.

2. To ensure the accuracy of the measurement, wait at least 30 seconds after 5 consecutive measurements.

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Mode conversion

• When the device is running, pressing the MODE button to cycle conversion between “body” mode and “surface” mode.

• “Body” mode is used for measuring human body temperature, the “surface “ mode is used to measure the surface temperature. (The factory default is “body” mode)

Recalling and Erasing Memory Data

The last temperature taken before the thermometer powers o is stored in memory, up to 50.

1. In the boot or shutdown state, short press the MEMO button to view the history of measured values.

2. An empty memory cell shows “---°C” or “---°F”.

3. Temperature readings can be stored in memory. Up to 50 temperature readings can be stored into the memory cells and automatically overwrite historical data.

4. In boot mode, press the MEMO button until the LCD display “CLR”, which means that all stored data is cleared completely.

Parameter settings

As below step:

1. Unit Set-F1 Under the boot mode, long press the “MODE” button to enter F1, press the “MODE” or “MEMO”button to switch Celsius and Fahrenheit temperature units, press the On/ Scan button to conﬁrm the unit settings (factory default is Celsius).

2. Fever alert set-F2 Under F1 state, press ON/scan button to enter the F2, press the “MEMO” button to decrease 0.1°C, press the “MODE” button plus 0.1°C, long press to accelerate the speed of temperature regulation, and ﬁnally press the ON/scan button to save. (The factory default is 38.1°C)

3. Prompt sound settings-F3 Under F2 state, short press ON/scan button to enter F3, press MODE button or MEMO button to set voice switch, and press the ON/scan button to conﬁrm the settings. (The factory default is the voice Prompt to open).

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• Prompt sound settings ON/OFF function

Under the boot mode. Short press on/o button, at the same time press the “MODE” button to take on or take o the Prompt sound function.

• Restore to factory setting function Under the boot mode, short press on/o button, at the same time press the MEMO button until LCD display “rst”. Two seconds later, former F1-F3 parameter back to factory setting.

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TROUBLESHOOTING

Message Situation Solution

Temperature taken in not within Typical human temperature range. (34.0°C ~ 43.0°C or 93.2°F ~ 109.4°F).

Measured over the distance: 1-5cm (0.4-2in) Optimum measurement distance is 1cm

Incorrect test position. See ﬁgure 2 Measuring position and distance.

Subjects forehead hair, Antipyretic stickers, head with sweat, etc.

Some people’s body temperature is lower than the general population.

Operating temperature exceeds the range of speciﬁed temperature.

The screen ﬂicker, automatic turn o.

Battery capacity is too low. Taking Temperature is not allowed.

Ambient temperature changes too fast Wait until the ambient temperature is stable.

1. Power is o.

2. Improper battery installation.

3. The battery is exhausted.

4. Display remains blank.

Make sure the forehead thermometer is for forehead measurement, not other human body site.

Subjects sit quietly 5-10 minutes before the test.

The main concern fever temperature

Move to a room within the operating range wait 30 minutes before taking temperature.

Replace battery or the product has been damaged, needs repairs.

Install a new battery

1. Press ON button again.

2. Check the battery polarity.

3. Replace with a new battery.

4. Contact the retailer or service center.

REPLACING THE BATTERY

1. Open and release battery cover following indicator on the surface of battery cover. Before changing the battery be sure the thermometer is already turned o.

2. Remove the battery and replace with 2 new type AAA batteries, Make sure to align properly as indicated inside the battery cover.

3. Slide the battery cover back in until it snaps in place. Do not dispose of used batteries in household waste. Take them to special local collection sites.

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4. If the thermometer appears frozen after changing the batteries, remove batteries, wait 30 seconds and replace batteries again.

WARNING Do not recharge, disassemble or dispose of in ﬁre.

1. The typical service life of the new and unused batteries is 2000 measurements for the operation time is 18s.

2. Only use the recommended batteries, do not recharge non-rechargeable batteries and do not burn them.

3. Remove the batteries if the thermometer is not to be used for a long period.

CLEANING, CARE AND STORAGE

• The lens is very delicate.

• It is very important to protect the lens from dirt and damage.

• Use a clean, soft cloth to clean the surface of the device and LCD. Do not use solvents or immerse the device into water or other liquids.

• Always keep the thermometer within the storage temperature range (- 20°C to 55°C or – 4°F to 131°F) and humidity range (≤93% non-condensing).

• It is recommended to store the thermometer in a dry location free from dust. Do not expose the thermometer to direct sunlight, high temperature/ humidity or any extreme environment, otherwise the function will be reduced.

• When the ambient temperature of the thermometer changes too much, such as moving the thermometer from one place of lower temperature to another place of higher temperature, allow the thermometer to remain in a room for 30 minutes where the temperature is between 15°C to 40°C.

DISPOSAL

• Used batteries should not be disposed of in the household rubbish. Used Batteries should be deposited at a collection point.

• At the end of its life, the appliance should not be disposed of in household rubbish.

• Enquire about the options for environment-friendly and appropriate disposal. Take local regulations into account.

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WARRANTY

Our company warrants Non-Contact Infrared Body Thermometer at the time of its original purchase and for the subsequence time period of 2 years.

The warranty does not cover the followings:

• The device series number label is torn o or cannot be recognized.

• Damage to the device resulting from misconnection with other devices.

• Damage to the device resulting from accidents.

• Changes performed by users without the prior written authorization of the company.

• Batteries and packaging are not covered under warranty

When asked to provide warranty service, you must have a purchase date and purchase stamp dealers (including dealers name and address) of the warranty card. Be sure to ask the dealer to purchase this product signature on the warranty card. When asked to provide warranty service, please put the product to get our distribution points for repair. Products outside the warranty expires, will be charged accordingly.

Note:

1. If you have any problems with this device, such as setting up, maintaining or using, please contact with SERVICE PERSONNEL of FKA Brands Ltd. Don’t open or repair the device by yourself.

2. Please report to FKA Brands Ltd if any unexpected operation or events occur.

3. Calibration needed to ensure proper function for every two years or after device impact.

4. The patient is an intended operator. The patient can measure and change battery. Under normal circumstances and maintain the device and its accessories according to the user manual.

EMC DECLARATION

1. This equipment needs to be installed and put into service in accordance with the information provided in the ACCOMPANYING DOCUMENTS; This product needs special precautions regarding EMC and needs to be installed and put into service according to the EMC information provided, and this unit can be aected by portable and mobile RF communications equipment.

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2. * Caution: Do not use a mobile phone or other devices that emit electromagnetic ﬁelds, near the unit. This may result in incorrect operation of the unit.

3. *Caution: This unit has been thoroughly tested and inspected to assure proper performance and operation!

4. * Caution: this machine should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary, this machine should be observed to verify normal operation in the conﬁguration in which it will be used.

Guidance and manufacturer’s declaration-electromagnetic emissions

The Non-Contact Infrared Body Thermometer is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the Thermometer should assure that it is used in such an environment.

Emissions test Compliance

RF emissions CISPR 11 Group 1

RF emissions CISPR 11 Class B The Non-Contact Infrared Body

Harmonic emissions IEC 61000-3-2

Voltage ﬂuctuations Flicker emissions IEC 61000-3-3

Not applicable

Electromagnetic environment guidance

The Non-Contact Infrared Body Thermometer uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.

Thermometer is suitable for use in all establishments other that domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

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Guidance and manufacturer’s declaration-electromagnetic immunity

The Thermometer is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the Thermometer should assure that it is used in such an environment.

Compliance

Immunity test IEC 60601 test level

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 61000-4-5

Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic ﬁeld IEC 61000-4-8

NOTE UT is the a.c. mains voltage prior to application of the test level.

±6kV contact ±15kV air

±2 kV for power supply lines ±1 kV air for input/ output lines

+/- 1kV line(s) to line(s) =/- 2kV line(s) to earth

<5% UT (>95% dip in UT for 0.5 cycle 40% UT (60% dip in UT for 5 cycles 70% UT (30% dip in UT for 25 cycles 5% UT (>95% dip in UT for 5 sec

30 A/m 30 A/m

Electromagnetic environment-

level

guidance Floor should be wood, concrete or

±6kV

ceramic tile. If ﬂoors are covered

contact

with synthetic material, the relative

±15kV air

humidity should be at least 30%.

Mains power quality should be that

Not

of a typical commercial or hospital

applicable

environment.

Mains power quality should be that

Not

of a typical commercial or hospital

applicable

environment.

Mains power quality should be that of a typical commercial or hospital environment. If the use of the Thermometer requires continued

Not

operation during power mains

applicable

interruptions, it is recommended that the Thermometer be powered from an uninterruptible power supply or a battery.

Power frequency magnetic ﬁelds should be at levels characteristic of a typical location in a typical commercial or hospital environment.

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Guidance and manufacturer’s declaration-electromagnetic immunity

The Thermometer is intended for use in the electromagnetic environment speciﬁed below. The customer or the user of the Thermometer should assure that it is used in such an environment.

IEC 60601

Immunity test

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reﬂection from structures, objects and people.

a. Field strengths from ﬁxed transmitters, such as base stations from radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast can not be predicted theoretic call with accuracy. To assess the electromagnetic environment due to ﬁxed RF transmitters, an electromagnetic site survey should be considered. If the measured ﬁeld strength in the location in which the Thermometer is used exceeds the applicable RF compliance level above, the Thermometer should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the Thermometer. b. Over the frequency range 150kHz to 80MHz, ﬁeld strengths should be less than 10 V/m.

test level 3Vrms

150kHz to 80 MHz

10 V/m 80MHz to

2.5 GHz

Compliance level

Not applicable

10 V/m

Electromagnetic environment-guidance

Portable and mobile RF communications equipment should be used no closer to any part of the Thermometer, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance. d=1.2 d=1.2 80 MHz to 800 MHZ d=2.3 800 MHz to 2,5 Ghz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m). Field strengths from ﬁxed RF transmitters, as determined by an electromagnetic site survey,” a. should be less than the compliance level in each frequency range.” b. Interference may occur in the vicinity of equipment marked with the following symbol:

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Recommended separation distances between portable and mobile RF communications equipment and the Thermometer

The Thermometer is intended for use in an electromagnetic environment in which radiated RF distances are controlled. The customer or the user of the Thermometer can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Thermometer as recommended below according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter / W

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73 1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is aected by absorption and reﬂection from structures, objects and people.

Separation distance according to frequency of transmitter / m

150 kHz to 80 MHZ

d=1.2

80 MHz to 800 MHZ

d=1.2

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800 MHz to 2.5 GHz

d=2.3

BODY TEMPERATURE

• Body temperature varies from person to person and ﬂuctuates during the course of the day. For this reason, it is suggested to know one’s normal, healthy forehead temperature to correctly determine the temperature.

• Body temperature runs approximately from 35.5°C to 37.8°C (95.9°F-100°F). To determine if one has a fever, compare the temperature detected with the person’s normal temperature. A rise over the reference body temperature of 1°C (1°F) or more is generally indication of fever.

• Dierent measurement sites (rectal, axillary, oral, frontal, auricular) will give dierent readings. Therefore it is wrong to compare the measurement taken from dierent sites.

• Here below are typical temperatures for adults, based on dierent measurement sites:

Rectal: 36.6°C to 38°C /97.9°F-99.1°F Axillary: 34.7°C to 37.3°C /94.5°F-99.1°F

ASTM laboratory accuracy requirements in the display range of 37°C (98°F to 102°F) for IR thermometers is ±0.2.(±0.4°F), whereas for mercury in-glass and electronic thermometers, the requirement per ASTM Standards E667-86 and E1112-86 is ±0.1.(±0.2°F).

Caution: This infrared thermometer meets requirements established in ASTM Standard (E1965-98) Except of clause 5.2.2. It displays subject’s temperature over a range of

34.0°C ~43.0°C. Full responsibility for the conformance of this product to the standard

is assumed by (Hetaida Technology Co., Ltd. Add: 4F, Baishida High-Tech Park, Xiandong Industrial Area, Dalingshan Town, Dongguan City, Guangdong, China).

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AVANT-PROPOS

Le mode d’emploi du thermomètre infrarouge sans contact a été rédigé aﬁn de donner les informations nécessaires au bon fonctionnement du modèle de thermomètre. Seule la prise de mesure corporelle a été examinée et certiﬁée par l’organisme notiﬁé. Une connaissance générale du thermomètre infrarouge et une compréhension des caractéristiques et fonctions du modèle de thermomètre sont des conditions préalables à toute utilisation appropriée. Le thermomètre corporel infrarouge sans contact est un appareil médical que vous pouvez utiliser de façon répétée et dont la durée de vie est de 5 ans. Veuillez lire ce mode d’emploi avant de l’utiliser ; si vous ne comprenez pas complètement les consignes données, veuillez cesser d’utiliser ce thermomètre.

N’utilisez aucun le thermomètre sans avoir lu et compris complètement ces instructions et consignes.

Important

L’achat ou la possession de cet appareil ne comporte aucune licence expresse ou implicite d’utilisation avec des pièces de rechange qui, seules ou en combinaison avec cet appareil, relèveraient de l’un des brevets associés.

Pour plus d’informations, contactez :

HoMedics Group Ltd, Somerhill Business Park, Five Oak Green Road, Tonbridge, Kent TN11 0GP. Customer Service: service@homedics.co.uk

Nom de la compagnie: Wellkang Ltd Adresse de la société: 16 Castle St, Dover, CT16 1PW, UK Tel: +44 (20)30869438, 32876300 Fax: +44(20)76811874 Web: www.CEmark.com, www.CE-marking.com, www.CE-marking.eu, Email: AuthRep@CE-marking.eu

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À PROPOS DE LA SÉCURITÉ

Cet appareil ne peut être utilisé qu’aux ﬁns décrites dans ces instructions et consignes. Le fabricant ne peut pas être retenu pour responsable des dommages causés par une application inappropriée. Le thermomètre corporel infrarouge sans contact est conçu pour minimiser les risques d’erreurs dans le programme logiciel en suivant les processus de conception technique du son et de la lumière, l’analyse des risques et la validation du logiciel.

MISE EN GARDE

Les mises en garde sont identiﬁées par le symbole de MISE EN GARDE.

• Le thermomètre corporel infrarouge sans contact est destiné aux utilisateurs à domicile et en soins primaires comme outil de dépistage. Veuillez lire attentivement le mode d’emploi, les accessoires, les instructions d’utilisation, toutes les informations de précaution et les spéciﬁcations avant utilisation.

• Ce produit est conçu pour mesurer la température du corps humain sur le front.

• Ne l’utilisez pas à d’autres ﬁns que celles prévues,

• Ce produit est destiné à l’usage domestique et pour les soins primaires comme outil

• de dépistage.

• N’utilisez pas le thermomètre s’il fonctionne mal ou a été endommagé de quelque manière que ce soit.

• Si l’écart de température entre l’endroit où le thermomètre est conservé et la pièce où la mesure sera prise est trop élevé, laissez le thermomètre à température ambiante dans cette dernière pendant un minimum de 30 minutes à une température comprise entre 15°C to 40°C (59°F- 104°F).

• Retirez les piles d’origine si l’équipement n’est pas susceptible d’être utilisé pendant une longue période.

• Ce produit n’est pas étanche, ne l’immergez pas dans l’eau ou tout autre liquide ; pour le nettoyer et le désinfecter, veuillez suivre les instructions et consignes de la section « Entretien et conservation ».

• Ne touchez pas la sonde de détection infrarouge avec vos doigts.

• Si une compresse froide a été posée sur les patients fébrile au front, ou si vous prenez d’autres mesures pour faire baisser la ﬁèvre, les données de température seront basses ; évitez dans ce cas de mesurer la température corporelle.

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• Si vous mesurez la température du front d’un patient, veuillez sélectionner la « prise de mesure corporelle » ; pour mesurer d’autres objets, liquides, aliments et autres températures, veuillez sélectionner la « prise de mesure en surface ».

• Veuillez utiliser ce thermomètre dans un environnement stable. Si cet environnement change et qu’il y a du brouillard sur le capteur, veuillez suivre les instructions et consignes indiquées à la section « Entretien et conservation » pour éliminer le brouillard.

• Ne vous approchez pas d’un champ électrostatique ou magnétique puissant, pour ne pas aecter la précision des données de mesure.

• Ne mélangez pas les anciennes et les nouvelles piles aﬁn d’éviter d’endommager le produit.

• Cela peut aecter la précision des mesures lorsque le front est couvert de cheveux, de transpiration, d’une casquette ou d’un foulard.

• Le résultat de mesure de ce produit est uniquement pour votre référence.

• En cas de doute, veuillez mesurer la température par d’autres méthodes.

L’appareil doit être conservé hors de portée des enfants / animaux domestiques. Veuillez conserver ce thermomètre, lorsqu’il n’est pas utilisé, dans une pièce sèche et protégez-le contre l’humidité extrême, la chaleur, les peluches, la poussière et la lumière directe du soleil. Ne placez jamais d’objets lourds sur le corps du

thermomètre. Ne jetez pas les piles au feu. Utilisez uniquement les piles recommandées. N’utilisez pas de piles rechargeables. Ce thermomètre ne remplace pas un diagnostic hospitalier, Ne faites pas tomber, ne démontez pas et ne modiﬁez pas le thermomètre. N’utilisez pas ce thermomètre si vous pensez qu’il est endommagé ou si vous

remarquez quelque chose d’inhabituel.

Cet appareil comprend des composants sensibles et doit être traité avec prudence. Respectez les conditions de conservation et de fonctionnement décrites dans la

section « Caractéristiques techniques ».

Pas d’entretien / maintenance lorsque le thermomètre est en cours d’utilisation. Lors de l’utilisation, ne touchez pas la pile et le patient simultanément. N’utilisez pas le thermomètre s’il est endommagé / dégradé / desserré dans ses

parties de quelque façon que ce soit. L’utilisation continue d’un thermomètre

endommagé peut causer des blessures, des résultats incorrects ou un grave danger. D’autres réactions allergiques potentielles sont inconnues après la science et la

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technologie actuelles.

Cet équipement doit être installé et mis en service conformément aux informations

données dans les DOCUMENTS QUI L’ACCOMPAGNE.

PRÉSENTATION

Usage prévu

Les thermomètres infrarouges pour le corps HoMedics sans contact sont conçus pour être utilisés pour la mesure et la surveillance intermittentes de la température du corps humain par les consommateurs à domicile et en soins primaires comme outil de dépistage.

Description du thermomètre infrarouge sans contact

• Principe de l’appareil et introduction

• Le thermomètre corporel infrarouge HoMedics sans contact est un appareil portatif, réutilisable, fonctionnant sur batterie, qui peut mesurer la température du corps humain sur le front, la température de la peau sur le front.

• Le principe de fonctionnement se base sur la technologie des capteurs infrarouges.

• Le capteur IR peut émettre un signal diérent lors de la mesure de diérentes températures d’objet ou à diérentes températures ambiantes, et l’ASIC peut

• transformer le signal du capteur IR en une valeur numérique et l’acher sur l’écran LCD.

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Figure 1: Non-Contact Infrared Thermometer

1. Capteur IR

2. Achage à cristaux liquides (LCD)

3. Bouton de stockage en mémoire MODE

4. Bouton de mémorisation MEMO

5. Bouton ON/scan

6. Couvercle du compartiment de la pile

7. Prise en mesure en surface

8. Prise de mesure corporelle

APPLICATIONS DU THERMOMÈTRE

Numéro de

modèle

du thermomètre

HTD8816C

TE-350-EU

Type de thermomètre

Thermomètres infrarouges sans contact

9. Indicateur de données

10. Indicateur de résultat de mesure

11. ndicateur de batterie faible

12. Indicateur marche / arrêt du voix

13. Numéro de mémoire

14. Fahrenheit

15. Celsius

16. Indicateur de mémoire

Adulte Enfant

Oreille Fron t Oreille Front

ü ü

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SYMBOLES D’ÉQUIPEMENT

1cm-5cm

Mise en garde Restriction des substances dangereuses

Emballage non stérile Code lot

Veuillez consulter le mode d'emploi

Température de fonctionnement

Humidité ambiante

Cet appareil est conforme à la partie 15 des règles de la FCC (Federal Communications Commission).

Fabricant

Conformité à la norme DEEE

NE PAS JETER Destiné à un usage multiple

Pression atmosphérique de fonctionnement

Indique que cet appareil est conforme à MDD 93/42/CEE. 0598 est le numéro de l’organisme notiﬁé

Représentant agréé dans la Communauté Européenne

Recyclable Numéro de série

Le premier numéro 2 : Protégé contre les corps étrangers solides de ‘V 12,5 mm et plus. Le deuxième numéro 2 : Protégé contre les gouttes d’eau tombant verticalement sur l’enveloppe

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CARACTÉRISTIQUES TECHNIQUES

Unité de mesure °C/°F

Mode de fonctionnement

Zone corporelle de référence

Plage de sortie nominale

Plage de sortie étendue Prise de mesure corporelle : 34.0 - 43.0°C / 93.2 - 109.4°F

Précision de laboratoire Prise de mesure corporelle

Résolution d’achage 0.1°C/0.1°F

Rétroéclairage tricolore (alarme couleur)

Temps de mise hors tension automatique

Durée des mesures ≤ 2s

Distance de mesure 1 - 5cm (0.4 - 2 “)

Mémoires 50

Mode ajusté (prise de mesure corporelle) Mode direct (prise de mesure en surface)

Axillaire

Prise de mesure corporelle : 34.0 - 43.0°C / 93.2 - 109.4°F Prise de mesure en surface : 0 - 100.0°C / 32 - 212°F

Prise de mesure en surface : 0 - 100.0°C / 32 - 212°F

34.0 - 34.9°C: ± 0.3°C / 93.2 - 94.8°F: ± 0.5°F

35.0 - 42.0°C: ± 0.2°C / 95.0 - 107.6°F: ± 0.4°F

42.1 - 43.0°C: ± 0.3°C / 107.8 - 109.4°F: ± 0.5°F

Prise de mesure en surface ± 2°C / ± 3.6°F

35.5 - 37.3°C / 95.9 - 99.1°F: Vert (température normale) ;

37.4 - 38.0°C (point d’alarme) / 99.3 - 100.4°F: Jaune (légère ﬁèvre)

38.1 - 43.0°C / 100.6 - 109.4°F: Rouge (ﬁèvre élevée) Remarque : 1. La prise de mesure en surface se fait toujours avec un rétro-éclairage vert.

2. Le mode prise de mesure corporelle ache toujours la température comprise entre 34,0 et 35,4 °C avec une rétro-éclairage vert

≤18s

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Exigences d’alimentation

Piles 2 x 1.5V (AAA) Pile alcaline (IEC Type LR03)

Plage adaptable 2,6V 3,6V

Conditions environnementales

Conditions de fonctionnement

Température de fonctionnement et de stockage

Dimension et poids

Poids (sans piles) 80g

Taille L:122mm X W:96mm X H:42mm

Conformité

Article Conforme à

Classiﬁcation des équipements Valeurs calculées des indicateurs selon

Type de protection Équipement alimenté en interne (sur batterie)

Degré de protection Partie non appliquée

Étiquettes du panneau avant et du boîtier

Température EN ISO80601-2-56:2017

Contexte : soins à domicile EN 60601-1-11:2015

Température de fonctionnement : 15 °C - 40 °C (59 - 104 °F), humidité relative 85 %, pression atmosphérique : 70 - 106 Kpa

Température de stockage : -20 - 55 °C / -4 - 131 °F, humidité relative 93 %, pression atmosphérique :70 - 106 Kpa

EN 60601-1: 2006+A1:2013, EN 60601-1-2: 2015

EN ISO15223-1:2016

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Valeurs calculées des indicateurs selon ISO 80601-2-56

Indicateurs Valeur calculée

Biais clinique, rcb

Deviazione standard, σj 0.14

Limites de l’accord, LA 0.26

Répétabilité clinique, σr 0.07

Remarque : la valeur ci-dessus est calculée à partir des données cliniques de HTD8818A.

-0.027

Classiﬁcation de sécurité de ME EQUIPMENT

Protection contre les décharges électriques Équipement ME, alimenté en interne

Partie appliquée Partie non appliquée

Protection contre la pénétration nocive d’eau ou de particules

Mode of operation Fonctionnement continu

Remarque : Non destiné à être stérilisé. Ne pas utiliser dans un ENVIRONNEMENT RICHE EN OXYGÈNE.

IP22

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